Kornimate/medical-research-clean huggingface dataset:
an open-label, multicenter, phase 1b/2 study of the safety and efficacy of krt-232 when administered alone and in combination with low-dose cytarabine (ldac) or decitabine in patients with acute myeloid leukemia (aml)

Conditions: Relapsed or Refractory Acute Myeloid Leukemia (AML); Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN)

Summary: this study evaluates krt-232, a novel oral small molecule inhibitor of mdm2, when administered alone and in combination with low-dose cytarabine (ldac) or decitabine for the treatment of adults with acute myeloid leukemia (aml) and aml secondary to myeloproliferative neoplasms (mpn). participants must be relapsed/refractory (having failed prior therapy) and will be assigned to receive monotherapy (krt-232 alone) or combination therapy (krt-232 with ldac or krt-232 with decitabine).


Eligibility criteria:
key inclusion criteria: * part a: patients with relapsed or refractory aml, or newly-diagnosed aml secondary to mpn * part b:patients with relapsed or refractory aml secondary to mpn (myelofibrosis \[mf\], polycythemia vera \[pv\], or essential thrombocythemia \[et\]); patients may have been treated with ≥1 prior lines of therapy for their aml secondary to mpn. * adequate hepatic and renal function * appropriate prior treatment with an flt3 or idh1/2 inhibitor where applicable key exclusion criteria: * patients who are tp53 mutation positive * prior treatment with an mdm2 antagonist therapy * patients treated with ≥ 18 g/m2 of cytarabine within the prior 90 days are not eligible to be treated with cytarabine on this study but may be treated with decitabine (for part a) . * patients previously treated with decitabine are not eligible to receive decitabine on this study but may be treated with cytarabine (for part a) . * patients who have received an allogeneic hsct within 90 days of enrollment or who have active graft-versus-host disease requiring active therapy (for part a) * allogeneic stem cell transplant within 3 months; autologous stem cell transplant within 3 months or active graft-versus-host disease prior to first dose of study treatment (for part b) * patients who have received immunosuppressive therapy for graft-versus-host disease within 1 month prior to enrollment into this study * patients who are eligible for an allogeneic hsct per the opinion of the investigator and have a donor. patients who are hsct-eligible in the opinion of the investigator, but who refuse a transplant, are eligible for the study. * patients with known cns involvement with aml, acute promyelocytic leukemia (apl), or a history of bleeding diathesis * patients who have had major surgery within 28 days prior to the first treatment with krt-232 * women who are pregnant or breastfeeding

Keywords: navtemadlin
an evaluation of the safety and efficacy of memantine in agitated patients with moderate to severe alzheimer's disease

Conditions: Alzheimer's Disease

Summary: about 65% of patients with severe alzheimer's disease (ad) will have symptoms of agitation. there are drawbacks associated with the currently available therapeutic interventions for agitation associated with alzheimer's disease. in a recent trial, in the group of patients with moderate to severe ad treated with memantine, there were fewer incidences of agitation. it is hypothesized that memantine will be effective in reducing the symptoms of agitation associated with moderate to severe alzheimer's disease.


Eligibility criteria:
inclusion criteria: * moderate to severe alzheimer's disease with a score greater than or equal to 4 on agitation/aggression domain of npi * stable dose of donepezil for 3 months exclusion criteria: * other evidence of psychiatric disorders * oncologic diagnosis * clinically significant gastrointestinal, renal, hepatic, endocrine or cardiovascular disease

Keywords: memantine hcl dementia agitation alzheimer disease
the effects of phenylephrine compared with those of placebo and pseudoephedrine on nasal congestion in subjects with seasonal allergic rhinitis (sar)(p04579)

Conditions: Rhinitis, Allergic, Seasonal

Summary: this is a phase 3, single-dose, investigator-blind, randomized, placebo-controlled, crossover study, conducted at a single site in austria, outside of the normal grass pollen season. an allergic reaction will be induced by exposing subjects to grass pollen in the vienna challenge chamber (vcc). subjects will receive a single dose of each of the following treatments according to a randomization sequence: phenylephrine 12 mg immediate-release capsule, pseudoephedrine 60 mg immediate-release tablet, and placebo capsule. there will be a minimum of a 5-day washout period between each treatment. subjects will complete symptom evaluations throughout the study. the nasal decongestant effects of phenylephrine will be compared to those of placebo using the subjective symptom evaluations. the safety profile (adverse events and vital signs) of the treatments will also be evaluated.


Eligibility criteria:
inclusion criteria: * skin test positive for the grass pollen allergen used in the chamber at screening or within the prior 12 months. * a negative urine pregnancy test at screening and at monthly intervals for female subjects of childbearing potential. * the following minimum scores at an evaluation time point during each of the 120-minute screening period challenge sessions: 1. nasal congestion score of at least 2 (moderate); 2. total nasal symptoms score of at least 6; 3. total non-nasal symptoms score of at least 2. * freedom from any clinically significant disease, other than sar, that would interfere with the study evaluations. exclusion criteria : * an upper or lower respiratory tract infection within 4 weeks before screening. * dependence upon nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids, in the opinion of the investigator. * a known potential for hypersensitivity, allergy, or idiosyncratic reaction to the study drug or excipients.
efficacy and safety of multisite cardiac resynchronization therapy

Conditions: Ventricular Tachycardia

Summary: cardiac resynchronization therapy (crt) is a proven therapy in patients with severe left ventricular (lv) dysfunction with ejection fraction (ef)\<35%., moderate to severe congestive heart failure and wide qrs in ecg. positive response presents as improvement in quality of life, decrease in congestive hrat failure symptoms and signs, improvements in echocardiographic measurements and longer survival. about 30% of the patients do not respond to this treatment. a decrease in clinical response to crt is expected in patients with those predictors: advanced age, male, ischemic etiology of cardiomyopathy, non-lbbb pattern in ecg, lack of mechanical dyssynchrony, large scar in lv, congestive heart failure stage iv, and non-cardiac co-morbidities (lung disease, pulmonary hypertension, renal failure and diabetes). there are few solutions to increase the rate of clinical response to crt, for example: endocardial pacing of lv or pacing a few simultaneous sites on lv. a study that investigated a method of simultaneous pacing on lv of patients with congestive heart failure and lbbb with qrs\>150ms has shown major improvement of cardiac contraction (increased dp/dtmax) compared to a single pacing site over a postero-basal or lateral wall site). implantation of pacemaker leads- one in right ventricle (rv) and two over lv, i.e. multisite cardiac resynchronization therapy (mscrt), has a few potential advantages, compared to conventional crt.


Eligibility criteria:
inclusion criteria: 1. patients with severe lv dysfunction, severe heart failure (nyha fc iii-iv and at least one hospitalization for congestive heart failure in the past 3 months before inclusion) on optimal medical treatment and that have narrow complex qrs or rbbb. these patients have an indication for icd implantation. 2. patients with conventional indications for crtd implantation and ef\ 150ms and severe heart failure (nyha fc\>iii). 3. patients with an indication for pacemaker implantation and an expected high rate of pacing (complete av block or prior to avn ablation) and a wish to avoid rv pacing (example: severe tr). 4. patients with refractory ventricular tachycardia and severe lv dysfunction (ef\<35%) that continue to have vt episodes despite antiarrhythmic drugs and despite recurrent vt ablations. those patients have indication for icd. 5. patients with conventional indications for crt but during implantation the anatomy is such that the site of implantation is not optimal (qrs\>200ms). in these cases we will add an electrode in the opposite branch of the coronary sinus. exclusion criteria: pregnancy * patients included in another study * patients that have other solutions that could avoid implantation (medications, ablation, etc

Keywords: lv- left ventricular crt- cardiac resynchronization therapy mscrt- multisite cardiac resynchronization therapy (p-pacemaker; d-defibrillator) bbb -bundle branch block
human single neuron recordings in epilepsy patients

Conditions: Epilepsy; Memory

Summary: this study uses single neuron recordings in pre-surgical epilepsy patients to uncover the neural mechanisms underlying memory formation and retrieval. a secondary aim is to improve diagnostic tools to identify epileptogenic tissue.


Eligibility criteria:
inclusion criteria: * interest in participation. * temporal lobe epilepsy that is clinically being investigated with implantations of depth electrodes as part of the pre-surgical epilepsy monitoring. * cognitive/language skills sufficient to follow experimental instruction and maintain focus on the experiment. exclusion criteria: * patient does not want to participate. * extra-temporal epilepsy, or electrode implantation strategy that does not allow the use of micro-macrowire electrodes. * cognitive/language skills insufficient to follow experimental instruction and maintain focus on the experiment.
betaferon® regulatory post-marketing surveillance

Conditions: Multiple Sclerosis; Clinically Isolated System

Summary: to identify problems/questions about following items in the clinical practice using betaferon 1. unknown adverse event (especially serious adverse event) 2. identification of adverse event occurred in the real practice 3. factors that may affect the safety of drug 4. factors that may affect the effectiveness of the drug


Eligibility criteria:
inclusion criteria: * patients with diagnosis of ms or cis and decision taken by the physician to prescribe betaferon * patients who have not participated in betaferon regulatory post marketing surveillance before. exclusion criteria: * exclusion criteria must be read in conjunction with local product information

Keywords: multiple sclerosis clinical isolated syndrome (cis)
effect on the electrocardiographic qt interval corrected for heart rate (qtc) in healthy subjects

Conditions: Alzheimer Disease

Summary: the purpose of this study is to determine the effect of bms-708163 on the qtc interval (qt interval corrected for heart rate).


Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 18 to 32 kg/m², inclusive. * women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) and men, ages 18 to 55 * healthy subjects exclusion criteria: * history of cardiac arrhythmias or palpitations associated with presyncope or syncope, or history of unexplained syncope * sexually active fertile men not using effective birth control (double barrier) if their partners are wocbp * women who are pregnant or breastfeeding * history of allergy or intolerance to moxifloxacin or any member of the quinolone class of antimicrobial agents * history of hypokalemia, history or family history of prolonged qt interval, or family history of sudden cardiac death at a young age * any clinically significant ecg abnormality * history of seizure disorders * history of drowning survival
virtual reality after breast reconstruction surgery

Conditions: Pain, Postoperative; Non-Opioid Pain Management; Virtual Reality

Summary: this is a pilot study of virtual reality (vr) non-opioid management for women undergoing mastectomy and implant-based reconstruction. study participants will receive specialized vr interventions, administered via vr headsets, to manage pain.

the primary objective of this study is to estimate the effect of utilizing vr on reducing opioid use in study participants undergoing mastectomy with implant-based reconstruction compared to the control group. investigators will follow patients throughout the course of their hospitalization and monitor outcomes including pain levels, medication requests, and satisfaction. eligible participants will receive a vr headset and instructed to use the vr every time they feel pain and before asking for a pain medication. they can take pain medications, if they choose to do so. at their post-op visit, study participants will be interviewed and asked questions regarding their experience with vr. pain level and medication use will be compared with similar individuals who undergo the same procedure but are not provided with a vr headset.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * women who plan to undergo mastectomy and implant-based reconstruction * written informed consent obtained from subject and ability for subject to comply with the requirements of the study. * able to read and comprehend english exclusion criteria: * current diagnosis of epilepsy, dementia, or other neurologic disease that may prevent use of vr headset and software * sensitivity to flashing light * diagnosis of motion sickness * pregnancy or a medical condition where the study participant is prone to frequent nausea or dizziness * current or recent (less than 6 months) use of opioids * individuals with psychiatric disorders, including those with delirium or other disorders that may involve hallucinations or psychosis
effect of treadmill training on balance after chemotherapy in children with acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia, Pediatric

Summary: purpose: the present research was conducted to study the effect of treadmill training on balance after chemotherapy in children with acute lymphoblastic leukemia. subjects and methods: forty children with acute lymphoblastic leukemia included in the current research ranged of age from 8 to 12 years. the children participated in this study were assigned randomly into two equal number groups (a and b). group (a) includes 20 children who received balance exercises, while group (b) includes 20 children who received the same balance exercises of group (a) and treadmill training. the treatment program was applied three sessions per week (60 min for every session) for 8 weeks. balance master system and biodex balance system were used to evaluate balance of all children in the three groups before and after the treatment program.

the current research is a randomized control trial to differentiate between the treadmill training on balance after chemotherapy in children with acute lymphoblastic leukemia. chemotherapy induced peripheral neuropathy is related to the intensity of treatment and dosage of chemotherapy which could affect the severity of its symptoms, it could result in serious problems like sensory changes and numbness , in case the sensory nerves were affected , muscle weakness and in-coordination in case the affected were the motor nerves. in addition to the psychological problems the patient experience as a result of cipn, the patient also experience physical problems like injuries, fear of fall results from lack of sensory perception and muscle power. treadmill training, motor training may favor proprioceptive feedback, leading to adjustments for adequate postural balance and functional performance. treadmill exercises stimulate the kinetic, kinematic, and temporal features of walking. these exercises improve the strength of the muscles of the lower extremities, enhance motor learning, improve functional abilities, and activate the locomotor control system

Eligibility criteria:
inclusion criteria: * able to recognize commands given to them, * understand our verbal command and encouragement, * and stand and walk independently without repeated falling exclusion criteria: * children with impairment of sensation or * other neurological or psychological problems, * tightness and/or fixed deformity of lower limbs, * any neurological, musculoskeletal, or mobility disorders, * cardiac anomalies, * vision or hearing loss
adjuvant treatment of breast cancer with 1-3 aflicted lymph nodes

Conditions: Breast Cancer

Summary: the purpose of this study is to determine whether a treatment with 4 cycles anthracycline + cyclophoshamide followed by administration of 4 cycles paclitaxel is more effective than therapy with 4 cy\<cles of anthracycline adminbistration followed by 4 cycles of paclitaxel


Eligibility criteria:
inclusion criteria: * women with histologically proven breast cancer (pt1/pt2/pt3, pn1, n0) * ecog performance status 0-1 * start of adjuvant therapy not later than 4 weeks after surgery * hematology: platelets at least 100xgpt/l, neutrophiles at least 2xgpt/l * normal liver function as defined by: bilirubine till 1.5 x normal value, sgot/sgpt till 1.25 x normal value * normal kidney function as defined by: creatine till 1.5 x normal value * negative pregnancy test for patients before menopause and effective contraception * written informed consent exclusion criteria: * prior radiation, chemotherapy, hormontherapy and immunotherapy * patients with more than 3 afflicted lymph nodes * afflicted lymph nodes on the cantralateal side and/or afflicted supraclavicular or intraclavicular lymph nodes * bilateral breast cancer or second carcinoma of the breast * inflammatory breast cancer and/or distant metastases * existing clinically relevant peripheral neuropathie * heart infection during the last 6 months or therapeutically not compensated heart failure or cardiac arrhythmias of at least lown ii * patients with active infections and/or not controlled hypercalcemia * pregnant or breastfeeding women or women of child-bearing age who do not use effictive contrazeptiva

Keywords: breast cancer with 1-3 afflicted axillary lymph nodes
a comprehensive assessment of altered embodiment in individuals with spinal cord injury

Conditions: Spinal Cord Injuries (SCI)

Summary: spinal cord injury (sci) occurs when trauma or other factors damage the spinal cord, disrupting the flow of sensory information from the body to the brain. this interruption can interfere with embodiment-the body awareness and physical sensations processed by the brain-sometimes leading to a phenomenon called disembodiment. for people with sci, disembodiment may appear as unusual body sensations, like feeling that a limb is in a different position than it actually is. such changes in body awareness can impact daily life, mental health, and rehabilitation outcomes. despite its importance, the study of embodiment in sci remains limited. this project aims to explore how sci alters embodiment, focusing on its specific characteristics, the effects on daily life, and the underlying brain activity as measured by functional magnetic resonance imaging (fmri). both people with and without sci will participate. procedure: participants will complete a single examination lasting 2 to 2.5 hours, including approximately 55 minutes in the mri scanner (with preparation and follow-up).


Eligibility criteria:
inclusion criteria for all participants: * age between 18 and 60 * normal or corrected-to-normal visual acuity * german or italian native speaker additional inclusion criteria only for individuals with sci: * diagnosis of traumatic spinal cord injury * lesion level below t1 (first thoracic vertebra) * time since injury \>= 12 months * residual sensation on the upper leg (sensory capability of 1 or higher on at least one leg in the dermatomes l2 and l3 for both light touch and pin prick). exclusion criteria for all participants: * pregnancy or breastfeeding * diagnosis of other psychiatric or neurological disorders (e.g. epilepsy, tumor in the central nervous system) * confirmed diagnosis of alcohol and/or drug abuse with active consumption within the last 6 months * confirmed diagnosis of traumatic brain injury, intended as visible changes in the brain diagnosed by a radiologist * stroke * inability to perform study procedures (e.g. inability to consent) additional exclusion criteria for both hc and sci undergoing the fmri procedure: * active medical devices (e.g. cardiac pacemaker) * inability to perform study procedures (e.g. claustrophobia)

Keywords: spinal cord injury embodiment bodily sensations magnetic resonance imaging daily life
risk factors of psychiatric disorders and sexual dysfunction in infertile men

Conditions: Anxiety; Depression; Sexual Dysfunction; Infertility

Summary: to investigate the prevalence of psychological symptoms and sexual dysfunction, and to estimate their possible interactions in infertile men.

although psychological disorders such as anxiety and depression are known to be associated with sexual dysfunction, and their interactions have been reported by many studies, particularly the prevalence of these two aspects and the relationship between them in infertile men in china have not been well investigated. the investigators' aim is to evaluate the prevalence of psychological symptoms and sexual dysfunction and interactions between them systematically by using validated questionnaires and scales.

Eligibility criteria:
inclusion criteria: * men who seek treatment for infertility (infertility is defined as the inability to conceive after 1 year of unprotected intercourse) * age ≥ 18 years * in a heterosexual, stable relationship for at least 1 year * able to read and speak chinese exclusion criteria: * inability to read and understand the questionnaire because of language difficulties * already evaluated during an earlier survey * men on medication that could have affected their ejaculatory and erectile function and/or psychological status

Keywords: anxiety depression sexual dysfunction infertility
study to evaluate the effect of megestrol acetate in weight loss in dementia patients

Conditions: Dementia

Summary: the purpose of this study is to demonstrate the efficacy of megestrol acetate in the gain of body weight in patients with primary or mixed dementia with a weight loss.

in all geriatric patients with dementia it was prove a weight loss independently if they are institutionalized or not.there are some previous studies that indicates the effect of the megestrol acetate in the weight gain of patients with cachexia-anorexia related with neoplasia. it seems that the mechanism of development could be the same between these patients and patients with dementia. it was described an important role of a group of cytokines ( il-6, leptin, neuropeptide y, tnfalfa) in the development of this nutritional alteration. some previous pilots studies indicates that megestrol acetate has and effect in geriatric and dementia patients with a weight loss of at least 5% in the last 6 months.

Eligibility criteria:
inclusion criteria: * patients diagnosed of primary or mixed dementia (cie 10criteria) * weihgt loss \>5% of habitual weight in the last 6 months and proteic-caloric malnutrition (mna \<17) * outpatients * patients that accept the participation in the study exclusion criteria: * vascular pure dementia and secondary dementias( vascular dementia, parkinson disease,etc) * dementia in a terminal phase: category of fast 7c in the reisber scale * concomitant treatment with steroids, androgens or other drugs with progestagens * weight loss secondary to neoplasia

Keywords: weight loss, appetite, dementia, megestrol acetate